Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

Analgesic Efficacy of Dexmedetomidine Added to Patient Controlled Epidural Analgesia for Patients Undergoing Major Abdominal Cancer Surgery

Dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Abdominal Cancer
• Intervention / Treatment: Procedure: TEA+DEX; Procedure: TEA

Detailed Description

The aim of modern anaesthetic practice is to insure the rapid recovery of patients with fewer complications and earlier hospital discharge.

Thoracic epidural anesthesia (TEA) has been established as a cornerstone in the perioperative care after thoracic and major abdominal surgery providing most effective analgesia. beyond its analgesic properties, TEA's effects on the postoperative neurohumoural stress response, cardiovascular Pathophysiology, and intestinal dysfunction have been in the focus of both clinical and experimental investigations for years.

dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients (21 years old or more),
• classified as American Society of Anesthesiologists (ASA) grade II and III,
• scheduled for elective major abdominal cancer surgery.

Exclusion Criteria:

• patients with coagulopathy,
• active neurological disease,
• cutaneous disorders at the epidural insertion site,
• allergy to the study medication
• and patients refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TEA+DEX group; Intra operative thoracic epidural injection of (bupivacaine 0.125% +fentanyl 2 mic/ ml) , initial bolus dose of 8 ml before skin incision followed by fixed rate infusion of 6 ml/h till end of abdominal layer closure. Postoperative, thoracic epidural injection of (bupivacaine 0.0625%+fentanyl 2 mic /ml + dexmedetomidine 0.5 mic/ ml) at infusion rate 6 ml /h and bolus dose of 3 ml with lockout time 10 min	Procedure: TEA+DEX; intra and post operative TEA infusion of (bupivacaine +fentanyl 2 mic/ ml+ dexmedetomidine 0.5 mic/ ml) Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 inter space was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.
ACTIVE_COMPARATOR: TEA group; Intraoperative,thoracic epidural injection of bupivacaine (0.125%+fentanyl 5 mic/ml ) ,initial bolus dose of 8 ml before skin incision followed by fixed rate infusion of 6 ml/h till start of abdominal layer closure. Postoperative, thoracic epidural injection of (bupivacaine 0.0625%+fentanyl 2 mic /ml) at infusion rate 6 ml /h and bolus dose of 3 ml with lockout time 10 min	Procedure: TEA; Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 interspace was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline. then, intra and post operative TEA infusion of bupivacaine 0.125%+fentanyl 2 mic/ ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores (dynamic VAS)	dynamic visual analogue scale (0-10) 0=no pain 10=worst imaginable pain	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in post operative MAP	Mean arterial pressure	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Principal Investigator: Alaa M. Elzohry, MD, Lecturer in Assuit university

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2017
• Primary Completion (ACTUAL): May 10, 2019
• Study Completion (ACTUAL): May 30, 2019

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: SECI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No